Epidural Technique: Does it Really Matter to the Patient?

Emory University

Status: Terminated

Conditions: Anesthesia

Treatments: Procedure: Dural puncture epidurals (DPE); Procedure: Traditional epidurals (EPI); Procedure: Combined-spinal epidural technique (CSE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03539796

IRB00098730

Details and patient eligibility

About

The main objective of this study will be to determine if the dural puncture epidural (DPE) provides superior analgesia and better patient satisfaction when compared to traditional epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE group is comparable to that of the CSE technique.

Full description

There are approximately 4 million child birth deliveries in US hospitals per year, and 1.3million of those births are via cesarean section (c-section). With this type of surgery, obstetric anesthesiology plays an important role. The main objective of this study will be to determine if the dural puncture epidural (DPE) provides superior analgesia and better patient satisfaction when compared to traditional epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE group is comparable to that of the CSE technique.

Enrollment: 57 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female parturient at Grady Memorial Hospital must meet one of the following:
• Parturient having a scheduled or elective cesarean section
• Parturient not having primary cesarean-section
• At least 18 years of age
• Subject has signed the informed consent

Exclusion criteria

• Parturient who is unable or unwilling to sign the consent form
• Parturient having primary cesarean section
• Parturient with known complex cardiac disease (ex...aortic/mitral stenosis, aortic aneurysms, congenital heart disease with residual defects...etc)
• Parturient with any contraindication to neuraxial anesthesia such as coagulopathy, infection, or patient refusal
• Parturient having a fourth or more cesarean section

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

57 participants in 3 patient groups

Dural puncture epidurals (DPE)

Experimental group

Description:

Dural puncture epidurals for cesarean section.

Treatment:

Procedure: Dural puncture epidurals (DPE)

Traditional epidurals (EPI)

Active Comparator group

Description:

Traditional epidurals (EPI) for cesarean section.

Treatment:

Procedure: Traditional epidurals (EPI)

Combined-spinal epidural technique (CSE)

Active Comparator group

Description:

Combined-spinal epidural technique (CSE) for cesarean section.

Treatment:

Procedure: Combined-spinal epidural technique (CSE)